metabolic works, page-9

I wonder if Metabolic management are aware that the US FDA just released NEW draft guidance regarding the development of obesity treatments? It was published just days ahead of Metabolic's pulling the plug.

This "guidance" is "non-binding" and it cautions that "If you want to use an alternative apporach contact the FDA staff responsible for implementing this guidance."

This does not mandate cast-in-concrete trial protocols.

Also, there is this key sentence in the guidance (page 5): "The lifestyle modification programs used in preapproval trials should be applicable to individual patients prescribed the product post-approval (i.e. programs should strike an appropriate balance between effectiveness and simplicity.)"

The import of this sentence is profound. It means that the trials should mimic the conditions under which the drug is to be prescribed and used in the real world once the drug is approved and has been commercialized.

There is no way that the conditions under which Metabolic's last trial of AOD9604 came anywhere close to real-world conditions.

And there is not a single word in this guidance that requires the kind of intensly monitored exercise and diet regimen that was implemented in the last trial.

Here's another one that I don't know if Metabolic followed through with: All the late stage (say after 50% of the trial period) dropouts are supposed to be weighed at the end ot the treatment period just as if they had stayed in the program.

This is interesting reading, and makes the recent decision all the more perplexing:

http://www.fda.gov/cder/guidance/7544dft.pdf